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A Florida stem cell clinic has been cited by the U.S. Food and Drug Administration for what the agency describes as serious problems that could pose health risks to patients.
The agency said Monday that it has cited US Stem Cell Clinic, of Sunrise, for marketing stem cell products without FDA approval and for "significant deviations from current good manufacturing practice requirements," including some that could affect the "sterility of their products, putting patients at risk."
"Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk," FDA Commissioner Dr. Scott Gottlieb said in a news release.
The FDA said it recently inspected US Stem Cell Clinic and found that it was processing fat tissue into stem cells derived from body fat and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious health problems. Those problems included Parkinson's disease, amyotrophic lateral sclerosis (Lou Gehrig's disease), chronic obstructive pulmonary disease (COPD) and heart disease, among others.
The FDA said it hasn't approved any biological products made by US Stem Cell Clinic for any use.
During an inspection, FDA investigators also found evidence of "significant deviations from current good manufacturing practices" in the production of at least 256 lots of stem cell products. Those deviations included "failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections."
US Stem Cell Clinic also tried to hamper the FDA's investigation during a recent inspection "by refusing to allow entry except by appointment and by denying FDA investigators access to employees," the agency said.
Interfering with an FDA inspection is a violation of federal law, the agency said.
The FDA said it wants to hear from US Stem Cell Clinic within 15 working days, detailing how the problems cited in the agency warning letter will be fixed. If the problems aren't corrected, the company faces such enforcement actions as seizure, injunction or prosecutions, the agency said.
Any adverse events suffered by patients treated at US Stem Cell Clinic should be reported to the FDA's MedWatch Adverse Event Reporting program.
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